Diabetes Mellitus, Type 2 study: Semaglutide Auto-Injector
Official title Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
ClinicalTrials.gov ID: NCT05780905
What this study is testing
What is Semaglutide Auto-Injector?
This is an investigational once-weekly injectable medicine being studied to see if it affects blood flow in the brain for people with type 2 diabetes. It is designed to help the body manage blood sugar levels by signaling the pancreas to release insulin and slowing down how quickly the stomach empties.
Also referred to as Ozempic.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if semaglutide changes how blood moves through the brain and affects the protective barrier around brain cells.
- Who it's for
- The study is looking for adults who have type 2 diabetes and a history of stroke or a transient ischemic attack (a temporary blockage of blood flow to the brain).
- What's involved
- Participants will be randomly assigned to take either semaglutide or a placebo (a pill with no active medicine). They will undergo brain scans using magnetic resonance imaging (MRI) at the start and after one year.
- Time commitment
- The study lasts one year and requires brain scans at the beginning and at the end.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65
You may be able to join if
- Men and women 40-65 years of age
- people with type-2 diabetes \>= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2...
- Medically stable
- Has not received any investigational drug in the past 6 months
- Willing to participate and sign informed consent.
You likely can't join if
- Contraindication to MRI or contrast agent
- eGFR\<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
- Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
- Unable to perform home-glucose monitoring
- Currently need more than 100 units of insulin daily
- Uncontrolled hypertension with systolic blood pressure (SBP)\>180 mmHg or diastolic blood pressure (DBP)\>100 mmHg
See the full eligibility criteria
- Men and women 40-65 years of age
- people with type-2 diabetes \>= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors
- Medically stable
- Has not received any investigational drug in the past 6 months
- Willing to participate and sign informed consent.
- Contraindication to MRI or contrast agent
- eGFR\<45 mL/min/1.73m2 (eGFR is a measurement of kidney function)
- Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention)
- Unable to perform home-glucose monitoring
- Currently need more than 100 units of insulin daily
- Uncontrolled hypertension with systolic blood pressure (SBP)\>180 mmHg or diastolic blood pressure (DBP)\>100 mmHg
- LDL-C\>130 mg/dL or not on stable statin therapy in the past 6 months
- Treatment with pioglitazone in the past 3 months
- History of pancreatitis
- History of myocardial infarction, stroke or transient ischemic attack
- History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Hypersensitivity to semaglutide or any of the product components
- Participating in other clinical trial
- Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or who are breastfeeding or who plan to become...
The study team makes the final eligibility decision.
Where it is enrolling
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.